BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Reported: May 25, 2022 Initiated: April 14, 2022 #Z-1096-2022
Product Description
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Reason for Recall
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
Details
- Recalling Firm
- Bio-Rad Laboratories, Inc.
- Units Affected
- 348 units
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, FL, HI, IA, IL, MI, MN, NE, NY, TN, TX, and WA. The countries of Czech Republic, France, Germany, and Italy.
- Location
- Redmond, WA
Frequently Asked Questions
What product was recalled? ▼
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack. Recalled by Bio-Rad Laboratories, Inc.. Units affected: 348 units.
Why was this product recalled? ▼
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 25, 2022. Severity: Moderate. Recall number: Z-1096-2022.
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